The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The null hypothesis of the study is that the proportion of patients achieving luteinizing hormone (LH) suppression to prepubertal levels at Month 6 is 80%.

Percentage of children with LH suppression to prepubertal levels at Month 6. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of children with LH, FSH, estradiol/testosterone suppression to prepubertal levels and triptorelin serum levels at Months 1, 2 ,3 ,6 ,9 and 12. Incidence of adverse events, changes in growth and sexual maturation. [ Time Frame: Each visit throughout the study ] [ Designated as safety issue: No ]

Two injections of the triptorelin 6-month formulation will be administered by the intramuscular route at an interval of 24 weeks. The total study duration per patients will be 12 months (48 weeks).

Eligibility

Ages Eligible for Study:

2 Years to 9 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

Onset of development of sex characteristics before 8 and 9 years in girls and boys, respectively (breast development in girls or testicular enlargement in boys according to the Tanner method), and candidate to receive at least 12 months of GnRH agonist therapy after study entry.

Known hypersensibility to any of the test materials or related compounds.

Use of anticoagulants (heparin and coumarin derivatives).

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467882